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Not yet recruiting NCT07509762

Exercise Programs in Women With PCOS

No phase Interventional Polycystic Ovarian Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Face-to-face exercise, Digital rehabilitation.
Who it may be relevant to
Registry conditions: Polycystic Ovarian Syndrome (PCOS). Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigation of the Effectiveness of a Digital Rehabilitation-Supported Combined Exercise Program in the Management of Polycystic Ovary Syndrome

Overview

This study aims to investigate the effectiveness of a digital rehabilitation-supported combined exercise program in women with Polycystic Ovary Syndrome (PCOS). Participants aged 18-40 years will be randomly assigned to one of three groups: a digital rehabilitation group, a face-to-face exercise group, and a physical activity counseling group. The intervention will last 8 weeks, with exercise performed three times per week. Outcomes will include DNA methylation, hormonal and metabolic parameters, anthropometric measurements, body composition, muscle strength, basal metabolic rate, physical activity level, quality of life, menstrual cycle regularity, exercise adherence and satisfaction.

Detailed description

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder associated with metabolic, hormonal, and reproductive dysfunctions. Exercise is a key component in the management of PCOS; however, adherence to exercise programs remains a major challenge.

This randomized controlled trial aims to evaluate the effectiveness of a digital rehabilitation-supported combined exercise program compared to face-to-face supervised exercise and physical activity counseling.

Participants aged 18-40 years will be randomly assigned into three groups:

1. Face-to-face exercise group 2. Digital rehabilitation group 3. Physical activity counseling group The intervention will last for 8 weeks, with exercise sessions conducted three times per week.

The face-to-face group will participate in supervised exercise sessions conducted by physiotherapist. The digital rehabilitation group will perform the same exercise protocol as the face-to-face group group online, live (synchronously), under the guidance of physiotherapist. The counseling group will receive physical activity recommendations.

Outcome measures will include epigenetic changes (DNA methylation), hormonal and metabolic parameters, anthropometric measurements, body composition, muscle strength, basal metabolic rate, physical activity level, quality of life, menstrual cycle regularity, exercise adherence and satisfaction.

Interventions

  • Behavioral Face-to-face exercise
    Participants will perform the same combined exercise program (aerobic and resistance exercises) delivered in person by the study team. Sessions are supervised directly in a clinical setting.
  • Behavioral Digital rehabilitation
    Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.

Primary outcome measures

  • Change in DNA methylation levels in women with PCOS [Time frame: Baseline and after 8 week]
Secondary outcome measures (12)
  • Hormonal Parameter Testosterone [Time frame: Baseline and after 8 weeks.]
  • Hormonal Parameter Luteinizing Hormone [Time frame: Baseline and after 8 weeks]
  • Hormonal Parameter Follicle-Stimulating Hormone [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter Fasting Blood Glucose [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter Insulin Level [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter High-Density Lipoprotein Cholesterol [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter Low-Density Lipoprotein Cholesterol [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter Total Cholesterol [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter Triglycerides [Time frame: Baseline and after 8 weeks]
  • Metabolic Parameter C-Reactive Protein [Time frame: Baseline and after 8 weeks]
  • Anthropometric Measurements Waist Circumference [Time frame: Baseline and after 8 weeks]
  • Anthropometric Measurements Hip Circumference [Time frame: Baseline and after 8 weeks]

Eligibility criteria

Inclusion criteria

  • Women aged 18-40 years diagnosed with PCOS according to the Rotterdam criteria (Rotterdam, 2003) and by a specialist physician.

The presence of at least two of the following three criteria will be considered sufficient for a diagnosis of PCOS according to the Rotterdam criteria: (i) history of irregular menstruation with oligo/anovulation, (ii) clinical and/or biochemical signs of hyperandrogenism, (iii) detection of polycystic ovary images on ultrasonography.

  • Having sufficient technological skills to participate in the treatment online (ability to use video conferencing applications)
  • Voluntary participation in the study

Exclusion criteria

  • Pregnant and breastfeeding women
  • Individuals with acute infections
  • Uncontrolled arrhythmia, hypertension, diabetes, and unstable angina pectoris
  • Impaired cooperation, orthopedic and neurological problems that may hinder assessment and program participation
  • Individuals with a history of lower extremity injury or surgery in the last six months
  • Individuals with class III obesity according to WHO classification (BMI > 40 kg/m2) (WHO, 2000)
  • Individuals receiving medical treatment for weight loss (liraglutide, semaglutide, orlistat, bupropion/naltrexone, thizzpatide) or participating in a structured diet program during the study period
  • Individuals actively participating in another exercise program
  • Individuals taking antihypertensive, insulin-sensitizing, or hormonal contraceptive drugs in the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Biruni University — Istanbul

Publications

  • Turan V, Mutlu EK, Solmaz U, Ekin A, Tosun O, Tosun G, Mat E, Gezer C, Malkoc M. Benefits of short-term structured exercise in non-overweight women with polycystic ovary syndrome: a prospective randomized controlled study. J Phys Ther Sci. 2015 Jul;27(7):2293-7. doi: 10.1589/jpts.27.2293. Epub 2015 Jul 22. PMID 26311969
  • Wright PJ, Burts C, Harmon C, Corbett CF. Availability and Use of Digital Technology Among Women With Polycystic Ovary Syndrome: Scoping Review. JMIR Infodemiology. 2025 Jun 12;5:e68469. doi: 10.2196/68469. PMID 40505084

Identifiers

NCT: NCT07509762 · 2025-KAEK-49-PCOS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗